NCT01850524 · OUTCOME
Change From Baseline in HRQOL Measured by EORTC-QLQ-MY20 Scale
IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2023-07-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline to approximately 9 years
What was measured
EORTC QLQ-MY20 was a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. The scale has 20 questions. Subscale and individual items include future perspective items 18-20, body image item 17, disease symptoms items 1-6, side effects of treatment items 7-16. Raw scores are averaged, and transformed to 0-100 scale, where higher score is better quality of life. Positive change indicates improvement.
Analysis population: ITT population included all participants who were randomized. Overall number of participants analyzed is the number of participants available for analyses. Number analyzed indicates the number of participants available for analysis at the given timepoint.
Groups in this outcome
Placebo + LenDex
Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
Ixazomib + LenDex
Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + LenDex | 352 |
|---|
| Ixazomib + LenDex | 350 |
|---|
Reported measurements
Disease Symptoms: Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + LenDex | 352 |
|---|
| Ixazomib + LenDex | 350 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + LenDex | 30.3 | 23.76 | Not reported | Not reported | Not reported |
|---|
| Ixazomib + LenDex | 29.2 | 22.97 | Not reported | Not reported | Not reported |
|---|
Disease Symptoms: End of Treatment
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + LenDex | 222 |
|---|
| Ixazomib + LenDex | 215 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + LenDex | -3.1 | 20.74 | Not reported | Not reported | Not reported |
|---|
| Ixazomib + LenDex | -5.3 | 22.44 | Not reported | Not reported | Not reported |
|---|
Side-Effects: Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + LenDex | 352 |
|---|
| Ixazomib + LenDex | 350 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + LenDex | 18.0 | 14.53 | Not reported | Not reported | Not reported |
|---|
| Ixazomib + LenDex | 17.6 | 15.04 | Not reported | Not reported | Not reported |
|---|
Side-Effects: End of Treatment
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + LenDex | 222 |
|---|
| Ixazomib + LenDex | 214 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + LenDex | 1.7 | 14.52 | Not reported | Not reported | Not reported |
|---|
| Ixazomib + LenDex | 3.3 | 15.91 | Not reported | Not reported | Not reported |
|---|
Body Image: Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + LenDex | 346 |
|---|
| Ixazomib + LenDex | 346 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + LenDex | 81.7 | 27.67 | Not reported | Not reported | Not reported |
|---|
| Ixazomib + LenDex | 81.2 | 29.11 | Not reported | Not reported | Not reported |
|---|
Body Image: End of Treatment
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + LenDex | 215 |
|---|
| Ixazomib + LenDex | 207 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + LenDex | -7.8 | 31.93 | Not reported | Not reported | Not reported |
|---|
| Ixazomib + LenDex | -2.3 | 29.66 | Not reported | Not reported | Not reported |
|---|
Future Perspective: Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + LenDex | 350 |
|---|
| Ixazomib + LenDex | 349 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + LenDex | 57.3 | 25.95 | Not reported | Not reported | Not reported |
|---|
| Ixazomib + LenDex | 55.0 | 28.47 | Not reported | Not reported | Not reported |
|---|
Future Perspective: End of Treatment
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + LenDex | 220 |
|---|
| Ixazomib + LenDex | 211 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + LenDex | 4.4 | 24.85 | Not reported | Not reported | Not reported |
|---|
| Ixazomib + LenDex | 6.0 | 25.69 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 23.76
- value
- 30.3
- group Id
- OG001
- spread
- 22.97
- value
- 29.2
- denoms
- counts
- group Id
- OG000
- value
- 352
- group Id
- OG001
- value
- 350
- units
- Participants
- title
- Disease Symptoms: Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 20.74
- value
- -3.1
- group Id
- OG001
- spread
- 22.44
- value
- -5.3
- denoms
- counts
- group Id
- OG000
- value
- 222
- group Id
- OG001
- value
- 215
- units
- Participants
- title
- Disease Symptoms: End of Treatment
- categories
- measurements
- group Id
- OG000
- spread
- 14.53
- value
- 18.0
- group Id
- OG001
- spread
- 15.04
- value
- 17.6
- denoms
- counts
- group Id
- OG000
- value
- 352
- group Id
- OG001
- value
- 350
- units
- Participants
- title
- Side-Effects: Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 14.52
- value
- 1.7
- group Id
- OG001
- spread
- 15.91
- value
- 3.3
- denoms
- counts
- group Id
- OG000
- value
- 222
- group Id
- OG001
- value
- 214
- units
- Participants
- title
- Side-Effects: End of Treatment
- categories
- measurements
- group Id
- OG000
- spread
- 27.67
- value
- 81.7
- group Id
- OG001
- spread
- 29.11
- value
- 81.2
- denoms
- counts
- group Id
- OG000
- value
- 346
- group Id
- OG001
- value
- 346
- units
- Participants
- title
- Body Image: Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 31.93
- value
- -7.8
- group Id
- OG001
- spread
- 29.66
- value
- -2.3
- denoms
- counts
- group Id
- OG000
- value
- 215
- group Id
- OG001
- value
- 207
- units
- Participants
- title
- Body Image: End of Treatment
- categories
- measurements
- group Id
- OG000
- spread
- 25.95
- value
- 57.3
- group Id
- OG001
- spread
- 28.47
- value
- 55.0
- denoms
- counts
- group Id
- OG000
- value
- 350
- group Id
- OG001
- value
- 349
- units
- Participants
- title
- Future Perspective: Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 24.85
- value
- 4.4
- group Id
- OG001
- spread
- 25.69
- value
- 6.0
- denoms
- counts
- group Id
- OG000
- value
- 220
- group Id
- OG001
- value
- 211
- units
- Participants
- title
- Future Perspective: End of Treatment
- denoms
- counts
- group Id
- OG000
- value
- 352
- group Id
- OG001
- value
- 350
- units
- Participants
- description
- EORTC QLQ-MY20 was a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. The scale has 20 questions. Subscale and individual items include future perspective items 18-20, body image item 17, disease symptoms items 1-6, side effects of treatment items 7-16. Raw scores are averaged, and transformed to 0-100 scale, where higher score is better quality of life. Positive change indicates improvement.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
- id
- OG000
- title
- Placebo + LenDex
- description
- Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
- id
- OG001
- title
- Ixazomib + LenDex
- param Type
- MEAN
- population Description
- ITT population included all participants who were randomized. Overall number of participants analyzed is the number of participants available for analyses. Number analyzed indicates the number of participants available for analysis at the given timepoint.
- reporting Status
- POSTED
- time Frame
- Baseline to approximately 9 years
- title
- Change From Baseline in HRQOL Measured by EORTC-QLQ-MY20 Scale
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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